More Clinical Trials Using Pharmacogenetics
Two years ago, we touched on the fact that integrating pharmacogenetics into clinical drug development could decrease costs and improve outcomes. Since then, this idea has gained even more popularity.
Part of this has been a bigger push by the industry. More drugs now include pharmacogenetic information in their labeling. Even previously approved drugs have had their labeling updated to reflect pharmacogenetic recommendations. People want this information. In fact, the availability of pharmacogenetic information was at the heart of a recent lawsuit against the makers of Plavix®.
The industry has taken note. “The application of pharmacogenomic approaches during drug development is an evolving process,” said the FDA in a Guidance for Industry published last year, “that begins with discovery and continues through confirmation of clinical efficacy and safety outcomes.”
In the guidance, the FDA recounted some of the best practices and uses of pharmacogenetic testing during drug development. One potentially useful application they highlighted was investigating outliers who experience unusual drug exposure or unexpected side effects. It’s possible that these complications have pharmacogenetic roots.
These tests can also be used proactively as well. In early-phase studies, pharmacogenetics can help differentiate responder populations and identify high-risk groups. “Prospectively genotyping subjects will identify those subjects who are at risk, so that they can (1) receive lower doses or (2) be excluded from PK studies,” said the FDA Guidelines.
Pharmacogenetic testing has always shown promise in helping drug development. Now these predictions are coming to term. And with more people considering the implications of pharmacogenetics, it’s likely that this push on the development side will go hand-in-hand with greater adoption in clinical practice as well.
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